A craniectomy is a medical surgical procedure commonly performed to manage intractable brain swelling, often caused by trauma or stroke. When a patient is managed using a standard craniectomy procedure, two surgeries are required. First, a craniotomy is performed, wherein a section of the skull is removed and then the skin or scalp is closed over the skull opening. The craniectomy allows for the brain tissue to expand through the opening to reduce intracranial pressure. After the brain swelling has receded, which may take several weeks or months, a second cranioplasty operation is required to replace the saved native bone material, or alternatively, to implant a prosthetic skull piece, such as a thin titanium skull plate. This second operation restores a solid covering over the skull opening or defect.
The removal of the skull section in the craniectomy allows the brain tissue to expand without restriction by the skull. Without the skull protection, the brain is vulnerable under the skin until swelling reduces in the following weeks or months, until the cranioplasty surgery takes place to repair the skull defect. During the interim between the craniectomy and the cranioplasty procedures, the patient normally wears a helmet to protect the brain. The cranioplasty surgery increases the high costs associated with patient care. The cranioplasty procedure also increases the patient risk, with potential brain damage from the significant manipulation of the brain which can cause intracranial hemorrhage and seizures, increased risk of infection, and wound breakdown. Also, prior to the cranioplasty, patients often develop headaches and have delays in their recovery due to the loss of normal intracranial pressure gradient provided by the skull.
Therefore, a primary objective of the present invention is the provision of a craniectomy surgical procedure which achieves both the decompression and relief of intracranial pressure and a protective solid covering over the skull opening, with only one surgical operation.
Another objective of the present invention is a provision of an improved cranial plate for use after a craniectomy.
A further objective of the present invention is a provision of a cranial plate having a gasket or spacer to position the plate above the skull.
A further objective of the present invention is the provision of a cranial plate having elastic, or moveable elements that exert a force to maintain the position of the plate relative to the skull and pulls the plate towards the skull as spacers resorb.
Still another objective of the present invention is a provision of an improved cranial plate with a spacer between the plate and the skull, with a spacer shrinking over time so that the plate settles onto the skull.
Yet another objective of the present invention is a provision of a cranial plate which can be implanted during a craniectomy operation, without the need for a follow up cranioplasty operation.
Another objective of the present invention is a provision of a surgical procedure wherein a portion of the skull is removed to expose the brain, and a plate is positioned over the skull, in the appropriate spatial relationship to the skull defect, and then over time settles onto the skull, without a second surgical procedure.
Still another objective of the present invention is a provision of a craniectomy surgical procedure wherein resorptive spacers or mechanical elements that contracted over time, are used between a patient's skull and a cranial plate.
A further objective of the present invention is a provision of the improved cranial plate which is economical to manufacture, simple to implant, and safe for the patient.
These and other objectives have become apparent from the following description.